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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceRestore, Itrel, Synergy, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantMedtronic Neuromodulation
7000 Central Ave., NE
Minneapolis, MN 55432
PMA NumberP840001
Supplement NumberS586
Date Received12/09/2024
Decision Date12/23/2024
Product Code LGW 
Advisory Committee Neurology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for manufacturing updates of metal strip resistors manufactured at Vishay Thin Film, an external supplier to Medtronic’s internal supplier – Medtronic Tempe Campus (MTC). The supplier requested updates include use of an existing sample preparation method, and a tolerance change on a negligible risk level feature for manufacturability
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